study of bafetinib (inno-406) as treatment for patients with hormone-refractory prostate cancer

Conditions: Hormone Refractory Prostate Cancer

Summary: this is a phase ii open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with hormone refractory prostate cancer.


Eligibility criteria:
inclusion criteria: * males age ≥18 years. * histologically confirmed diagnosis of adenocarcinoma of the prostate. * hormone-refractory prostate cancer having progressed despite androgen deprivation therapy that resulted in a castrated level of testosterone (\<50 ng/dl) or orchiectomy; with or without evidence of measurable or evaluable disease. * psa increase defined as 2 consecutive rises; first increase in psa occurred a minimum of 1 week from the reference value; increase in psa should be at least 25% above the reference value and absolute psa value should be \>5 ng/ml. * may have received no more than 1 prior chemotherapy regimen. prior immunomodulatory therapy (sipuleucel-t (provenge), interferon) is allowed. * must be taking a single agent lhrh agonist or antagonist, unless previously underwent orchiectomy. * ecog performance status 0-2. * able to swallow pills. * able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site. exclusion criteria: * chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment * exposure to any investigational agent within 30 days of the screening visit. * no prior flutamide (eulexin) and ketoconazole use within 4 weeks, bicalutamide (casodex) within 6 weeks or nilutamide (nilandron) within 6 weeks of study enrollment. * use of quadramet therapy during 2 months prior to study enrollment or metastron ever. * prior treatment with a tyrosine kinase inhibitor. * subjects who have started bisphosphonate therapy within 4 weeks of study enrollment are excluded. subjects treated with a stable dose of a bisphosphonate for \>4 weeks and the tumor has still progressed can be enrolled in the study. * known cns disease or cns metastases. * history of other malignancies within the last five years except curatively treated basal cell carcinoma or superficial bladder cancer. * laboratory values: screening serum creatinine greater than or equal to 1.5 x uln, alanine aminotransferase (alt) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (wbc) count \<3500/mm3, absolute neutrophil count \<1500/mm3, hematocrit level \<35% and platelets \<100,000/mm3. * history of abnormal bleeding or use of anticoagulant therapy. * clinically evident congestive heart failure \>class ii of the new york heart association (nyha) guidelines. * serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as lown iii, iv or v. * history of mi within 6 months or uncontrolled angina within 3 months. * severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, chronic renal disease, chronic liver disease. * known hiv infection. * uncontrolled active, infection. * substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. * any condition that in the opinion of the investigator is unstable and could jeopardize the subject's participation in the study.

Keywords: hormone refractory prostate cancer hrpc